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Poster session 21

1528P - A phase I/II trial investigating safety and efficacy of autologous TAC01-HER2 in relapsed or refractory solid tumors

Date

21 Oct 2023

Session

Poster session 21

Topics

Cell-Based Therapy;  Immunotherapy

Tumour Site

Gastric Cancer

Presenters

Daniel Olson

Citation

Annals of Oncology (2023) 34 (suppl_2): S852-S886. 10.1016/S0923-7534(23)01930-0

Authors

D. Olson1, E.E. Dumbrava2, M. George3, S. Saibil4, A. Giordano5, M. Gavrilliuc6, B. Pieke7, E. Lichtenstein8, M. Apostolopoulou9, K. Moss9, D. Kirkwood10, S. Dang10, D. Adib9, B.L. Schlechter11

Author affiliations

  • 1 Medicine, The University of Chicago, 60637 - Chicago/US
  • 2 Investigational Cancer Therapeutics Department, The University of Texas M. D. Anderson Cancer Center, 77030 - Houston/US
  • 3 Health, Rutgers Cancer Institute of New Jersey, 08903 - New Brunswick/US
  • 4 Immunology, UHN - University Health Network - Princess Margaret Cancer Center, M5G 2M9 - Toronto/CA
  • 5 Medical Oncology, Dana Farber Cancer Institute, 02115 - Boston/US
  • 6 Investifational Cancer Therapeutics, MD Anderson Cancer Center, 77030 - Houston/US
  • 7 Hematology/oncology, University of Chicago Department of Medicine - Section of Hematology/Oncology, 60637-1470 - Chicago/US
  • 8 Human Research Services, Rutgers Cancer Institute of New Jersey, 08903 - New Brunswick/US
  • 9 Clinical Development, Triumvira, 78733 - Austin/US
  • 10 Product And Process Development, Triumvira, 78733 - Austin/US
  • 11 Medical Oncology, Dana Farber Cancer Institute, 02215 - Boston/US

Resources

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Abstract 1528P

Background

Despite therapeutic developments for patients with advanced HER2+ solid tumors, significant unmet medical needs still exist. The T-cell antigen coupler (TAC) technology is an approach to modifying T-cells ex vivo, which allows recognition and cytotoxicity of tumor cells by co-opting the natural T-cell receptor. TAC T-cells demonstrate a safer profile than chimeric antigen receptor T cells. TAC01-HER2 is an autologous T-cell product comprising T-cells expressing HER2 TAC.

Methods

The ongoing clinical trial (NCT04727151) is evaluating the safety and preliminary anti-tumor activity of TAC01-HER2 treatment of HER2+ solid tumors. Subjects undergo leukapheresis followed by lymphodepletion chemotherapy (LDC) prior to TAC01-HER2 infusion. In phase I dose escalation, TAC01-HER2 is administered at increasing doses (Cohorts 1-4) in adult subjects after ≥2 lines of therapy. Dose limiting toxicities (DLT) are assessed up to 28 days from TAC01-HER2 infusion. In phase II, dose expansion groups will further evaluate the safety, efficacy, and pharmacokinetics of the optimal TAC01-HER2 dose in gastric/GEJ tumors.

Results

As of 23 April 2023, 19 patients with solid tumors have been treated in Cohorts 1-4. Three were HER2 1+ or 2+/FISH-. One DLT event of grade (G) 3 pneumonitis has been reported in 1 subject in Cohort 4. No neurotoxicity has been reported. Most subjects treated at Cohorts 3-4 experienced CRS which resolved with supportive therapy. Thirteen subjects have reported a total of 26 serious adverse events, with 1 G3 pneumonitis, 1 G1, 3 G2 and 1 G3 CRS related to TAC01-HER2. A 67% disease control rate (DCR) was observed in Cohorts 2-4 at 4 weeks restaging after TAC01-HER2 infusion. For gastric/GEJ subjects of the same Cohorts, DCR was 83%. Two patients had an unconfirmed partial response (uPR). At Cohort 4, a uPR was observed in a subject with GEJ (HER2 2+, FISH+) with 100% reduction of target lesion. This patient had progressed on 4 prior lines of therapy including trastzumab and trastuzumab deruxtecan.

Conclusions

Treatment with TAC01-HER2 showed manageable safety and promising clinical activity in a heavily pre-treated cancer population. Dose escalation is complete.

Clinical trial identification

NCT04727151.

Editorial acknowledgement

Legal entity responsible for the study

Triumvira Immunologics.

Funding

Triumvira Immunologics.

Disclosure

D. Olson: Financial Interests, Personal, Advisory Board: Novartis, Alphasights, GLG Consulting, MJH Life Sciences; Financial Interests, Institutional, Local PI: Takeda, Astellas, Adaptimmune, Instil Bio, Inhibrix; Non-Financial Interests, Principal Investigator: CTRL Therapeutics. E.E. Dumbrava: Financial Interests, Institutional, Other, Research/grant funding: Bayer HealthCare Pharmaceuticals, Immunocore Ltd., Amgen, Aileron Therapeutics, Compugen Ltd, Gilead, BOLT Therapeutics, Aprea Therapeutics, Bellicum, PMV Pharma, Triumvira, Seagen Inc, Mereo BioPharma 5 Inc, Sanofi, Rain Oncology, Astex Therapeutics, Sotio, Mersana Therapeutics, Poseida, Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker: PMV Pharma; Financial Interests, Personal, Advisory Board: Bolt Therapeutics, Mersana Therapeutics, Orum Therapeutics, Summit Therapeutics. M. George: Financial Interests, Personal, Advisory Board: Seattle Genetics, OBI Pharma; Financial Interests, Institutional, Research Grant: Incyte, Oncolytics. S. Saibil: Financial Interests, Personal, Advisory Board: Janssen, Novartis, Sanofi Genzyme. A. Giordano: Financial Interests, Personal, Advisory Board: Pfizer. E. Lichtenstein: Financial Interests, Institutional, Full or part-time Employment: Rutgers Cancer Institute of NJ. M. Apostolopoulou; D. Kirkwood; S. Dang: Financial Interests, Personal, Full or part-time Employment: Triumvira. K. Moss: Financial Interests, Institutional, Full or part-time Employment: Triumvira Immunologics, Inc.; Financial Interests, Personal, Stocks/Shares: Triumvira Immunologics, Inc. D. Adib: Financial Interests, Institutional, Officer: Triumvira; Financial Interests, Institutional, Stocks/Shares: Triumvira; Financial Interests, Institutional, Trial Chair: Triumvira. All other authors have declared no conflicts of interest.

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